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Clinical trials on rise, but many lack participants

Albert Plante found his clinical trials the old-fashioned way: through his doctor.

When his non-Hodgkins lymphoma recurred in 2009 and again in 2011, his longtime UC Davis Cancer Center specialist, Dr. Joseph Tuscano, suggested the clinical research treatments that have helped save Plante's life.

"I will try anything I can to get well," said Plante, now 76, a retired educator who lives in Roseville. "A clinical trial might get me well – but if it doesn't, it may present hope for somebody else."

With a graying population and a lot of unanswered questions, medical experts are urgently trying to figure out how to replicate the kind of spirit that motivates Plante to participate in clinical research.

The need for new participants – and perhaps new avenues to recruit them – is clear.

In the next two decades, deaths from cancer, Alzheimer's disease, diabetes and a host of other illnesses are poised to soar as the American population ages. Medical advances have already sliced the pie of disease into smaller and smaller biological slivers, making it possible to target a growing range of niche medications to specific subsets of illness.

But at the same time that science is identifying a growing number of potential new cures, the public is providing a smaller number of people willing to volunteer to help test the drugs needed to treat disease.

Today, 85 percent of drug trials face delays because attracting and retaining participants has become so challenging. According to the Tufts Center for the Study of Drug Development, enrollment rates have dropped 20 percent since 2000, with 2 million volunteers now participating.

Of the 1,000 new drugs being assessed in ongoing clinical trials, more than 700 treat age-related illnesses, according to the Center for Information and Study on Clinical Research Participation, a nonprofit dedicated to educating the public on the need for clinical trials. Almost two-thirds of cancer patients are older adults, as well as 85 percent of people with Parkinson's and 90 percent of people with diabetes.

By contrast, seniors represent only one-third of people volunteering for clinical trials, CISCRP data show.

Their reluctance to take part may stem from persistent negative public attitudes toward clinical trials. While 94 percent of people surveyed told CenterWatch, a global clearinghouse of clinical trial information, that they understood the importance of such research, more than 60 percent of people in a recent CISCRP poll said they didn't trust the safety of drug trials.

And about a third of those polled told CISCRP that they don't admire people who volunteer for those trials: Respondents thought the main reason people signed up was that they were ill and desperate.

Contrary to that view, the National Institutes of Health says that most clinical studies don't involve the development of new drugs, centering instead on prevention and diagnosis of illness and maintaining quality of life for people with chronic disease.

"Over the years, it's gotten harder and harder to attract research volunteers," said Ken Getz, a Tufts Medical School senior fellow and founder of CISCRP. "People hear about clinical research with passing interest at best and most not until they come to the point that they need a clinical trial."

Searching for ways to raise awareness about the role clinical research plays in public health, some advocates are turning to social media as an educational tool. But given the potential risks of such trials, others question whether new media represents an appropriate recruitment path.

Getz, for one, isn't a fan: He thinks that education, not outreach on Facebook and Twitter, holds the key to attracting more robust numbers of volunteers.

"People don't understand why research is important to health care," he said. "They don't understand the broader context."

So far, the medical community seems to agree. A new Tufts Center study shows that only 14 percent of clinical research organizations and pharmaceutical companies use social networking as a recruitment tactic, with the remainder preferring to rely on traditional avenues such as physician referrals.

The UC Davis Cancer Center highlights its more than 100 clinical trials on its website but does not actively recruit eligible patients online.

Partly that's because experts know that in drug trials – which are supposed to be strictly supervised by regulatory agencies and reviewed by ethics committees, or Institutional Review Boards – the use of social media can be cumbersome.

For example, researchers and doctors are the ideal people to communicate via social media with potential volunteers – but their online posts have to be IRB-approved, said Neil Weisman, executive vice president of Chicago-based Blue Chip Health Care Marketing, which helps drug companies develop campaigns to attract volunteers.

"Until there are better guidelines on how social media can be used, pharmaceutical companies are extremely reticent to adopt programs," he said.

Nonetheless, some advocacy groups have already found a measure of success with social media.

Since TrialMatch, the Alzheimer's Association online patient recruitment tool, debuted in 2010, about 32,500 people across the country have completed online profiles, and more than 5,200 have been matched with clinical trials.

"TrialMatch makes it easier for people to find a match that will work for them," said Elizabeth Edgerly, the association's Northern California chief program officer. "You used to have to sort through all sorts of information at all sorts of medical research centers."

But the numbers come up short: Another 20,000 volunteers nationwide are required to meet the needs of current Alzheimer's research, according to association figures.

UC Davis' Alzheimer's Disease Center has four trials under way, with several more in the recruitment phase, said center researcher Dr. John Olichney, a neurology professor.

One of those studies requires recruiting 1,000 older adults with healthy brains across the country willing to undergo annual brain scans to monitor deposits of beta amyloid, a protein associated with Alzheimer's.

"It's more of a problem recruiting people who are pre-symptomatic," he said. "There will be a lot of screening failures. We'll need 5,000 to 10,000 recruits overall.

"That's a lot of people not aware of any serious problems yet. They'll just be participating out of altruism."

Albert Plante would do it again.

Since his non-Hodgkins lymphoma diagnosis in 2000, he has undergone 220 chemotherapy infusions and 20 radiation treatments, received 58 pints of blood and 38 pints of platelets, been hospitalized almost a dozen times – and participated in two clinical trials.

The first helped researchers calibrate the dosage of medication needed to knock back his malignancy. The second involved testing a less toxic cocktail of medication used to prepare his bone marrow for a stem cell transplant.

Both helped Plante live.

"I'm so thankful I've had the opportunity to get the help I needed," he said. "But I would hope I helped save lives, too.

"I would hope it worked out that way. If they learned something from me and it worked on somebody else, God bless them."

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